Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine

• Status: Terminated
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Eli Lilly and Company
• Treatments: Olanzapine

Criteria

Inclusion Criteria:

• The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic

• The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days.

• Subject has been treated with lithium in the past.

• Subject has been treated with divalproex or carbamazepine in the past.

• Subject has been treated with Haldol or haloperidol in the past.

Exclusion Criteria:

• Subjects lacks the capacity to provide informed consent

• Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators

• Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.